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Quality Audit - A Tool for Continuous Improvement and Compliance

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White Paper 1 Quality Audit - A Tool for Continuous Improvement and Compliance Introduction The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store, or an assessment of the methods and procedures used in a scientific research study. In these examples, a systematic attempt is made to take a closer look at something – whether financial statements, a factory process, customer service or a research study – for the purpose of evaluation and, ultimately, decision making. The fact that the audit process casts auditors on one side and those being audited on the opposite side has created a general impression that auditing is adversarial. While a point-and-blame atmosphere may indeed exist in some cases, more and more organizations recognize that an audit does not have to be a negative experience or a dreaded event – when implemented properly, audit can be one of the most effective means for improvement. In nearly every industry, audit is increasingly used as an important management, compliance, quality and process improvement tool; in government-regulated and ISO environments, audit – both compliance and performance – is critical. Considering the type of products that the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulatory bodies govern, and the diversity of the industries in which ISO quality standards are applicable, auditing for the purpose of maintaining high quality standards directly impacts public health and safety. In these environments, the audit process is closely associated with quality and directly related to regulatory compliance. Regulations & Standards The International Organization for Standardization (ISO), the world's leading developer of international standards, was instrumental in boosting interest in quality audits among manufacturers and other types of businesses when it published the ISO 9000 standards in 1987. Today, popular standards such as ISO 9001, ISO 14001 and ISO 13485 all require internal audits of the quality system (or the environmental management system in the case of ISO 14001). Under these standards, audit serves as a mechanism for evaluating and improving quality. The same principle is reflected in a number of regulations enforced by the FDA. Under the FDA's Quality System Regulation (QSR) 21 CFR Part 820, medical device manufacturers are required to conduct audits to ensure that the quality system is compliant (Sec. 820.22). The Current Good Manufacturing Practice (CGMP) regulations for pharmaceuticals (21 CFR Parts 210-211) and for blood and blood components (21 CFR Part 606) include general requirements for regular evaluation of quality standards. Guidance for the pharmaceutical industry and blood establishments

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